Celegence

Celegence provides global regulatory affairs consulting/services and proprietary technology solutions to life sciences companies across all stages of the product lifecycle. Their services include regulatory strategy, medical writing, electronic submissions management, labeling compliance, data governance, and automation through AI-powered tools such as CAPTIS. They do not have a therapeutic pipeline but have supported clients in achieving rapid approvals (e.g., fastest EU MAA approval for a monoclonal antibody in an ultra-orphan indication). They serve pharmaceutical companies (small molecules, biologics, generics, biosimilars, advanced therapies) as well as medical device/in vitro diagnostics firms. Their value proposition centers on improving regulatory accuracy (>95%), reducing manual effort via automation (~50% faster delivery), and cost savings (~30%).